| Objective:The absorbable material has been gradually developed and applied in clinical treatment as a new kind of biomaterial in recent years. The material itself has many advantages such as good compatibility, biodegradability。Its property such as molecular weight can be manipulated in composing process. This study is to develop a new cervical cage made of absorbable material, Poly-DL-lactic Acid (PDLLA), and put it into clinical experiment to observe and evaluate its clinical effect, to research its significance of clinical application, at the base of completing the experiments of animal , biomechanics, histocompatibility, and so on. This study focuses on the clinical experiment, which will offer basic information for its further development and clinical application. Method: Design the cage made of absorbable material by consulting relative domestic and overseas literatures in recent years.The cases with cervical spondylosis in the EG are treated by the cervical anterior decompression, bone graft and interbody fusion with the CADFC. They are followed up. There are all inclusive in the observation including local reaction,fusion rate of the bone graft, complication and improvements of the cervical antecurvature , the height of vertebral body and intervertebral space and the spinal cord function. The bone vicariousness of CADFC are also observed. To evaluate the clinical effect of CADFC, compared with the cases in the CG treated by bone graft and interbody fusion with autogenous iliac crest. Result: The cervical cage was successfully made which was cubic type and made of 80*104 molecular weight PDLLA absorbable material. It corresponded with the standard of clinical experiment. All of the cases were followed up. The follow-up time was 6 months. In the EG, the appraisals of the local reaction and improvement of the spinal cord function were satisfactory without any preoperative or postoperative complication. The fusion rate of bone graft was 96.2% after 3 months and 100% after 6 months. The perioperative differences of the cervical antecurvature and the height of vertebral body and intervertebral space were both significant. But there were not conspicuous in the postoperative differences of them. CADFC could be absorbed and substituted by bone tissue gradually. But the progress need longer time. The EG was same with the CG in local reaction,fusion rate of the bone graft and improvement of the spinal cord function. The EG presented better results than the CG in complications and improvements of the cervical antecurvature and the height of vertebral body and intervertebral space. The evaluation of CADFC clinical effect was favorable. Conclusion: The design of CADFC is consistent with the requirements of absorbable interbody fusion cage in physiology and biomechanics. With nice histocompatibility, CADFC can be absorbed and substituted by bone tissue gradually. At the same time, it can supply enough intension for the whole progress of bone graft fusion, strengthen the stability of titanium plate and provent the subsidence of the cage. So it has high fusion rate of bone graft. CADFC avoids the shortage of common fusion cages and cuts down the incidence rates of some complications caused by grafting a massive iliac crest. The effects are conspicuous in recovering the spinal cord function, anastating and retaining the cervical physiological antecurvature and the height of vertebral body and intervertebral space. All of these indicate that the clinical effect and evaluation of CDAFC are both nice in the cervical anterior operation. So it is concluded that CADFC is a good new kind of cage which satisfies the requirement of vertebra fusion and will have a favorable clinical application prospect. Improvement of its degradation in the late fusion stage and its bone-growth ability will accelerate its application in clinical treatment. |
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